LifeBridge Health Home LifeBridge Health Department of Research Institutional Review Board (IRB)

Institutional Review Board (IRB)

	General Information
	Meeting Schedules and Submission Deadlines
	Initial Submission Documents
	Guidelines
	Renewal Submission Forms
	IRB Fees
	HIPAA Policy
	Education Requirements
	HIPAA Appendices
	Guidance and Regulatory Links

The LifeBridge Health Institutional Review Board (IRB) ensures that the rights and welfare of human subjects participating in research are adequately protected, the risks to subjects are outweighed by the potential benefits of the research, the selection of subjects is not coercive or biased, informed consent will be obtained and documented where appropriate, and there is scientific merit to the proposal.

IRB Information

Policies and Standard Operating Procedures
LBH Conflict of Interest Policy
LifeBridge Health Research Policy
Misconduct-in-Research Policy
IRB (A) Membership Roster 2010
IRB (B) Membership Roster 2010

Meeting Schedules and Submission Deadlines

2010 Deadlines and Meeting Dates for IRB A

2010 Deadlines and Meeting Dates for IRB B

 

Initial Submission Documents:

Expedited and Full Board Reviews:

Studies involving human research subjects may qualify for expedited review.  The application documents for expedited and full board review are the same.  However, studies that qualify for expedited review may be reviewed by the Chairman or his designee rather than by the full board.  Please review the Application for New Research to determine how many copies are needed.

Application Checklist

Application for New Research

Co-Investigator Signature Form

Investigator Delegation Form

Financial Interest Disclosure

Study Summary

Consent Form Template

HIPAA Text for Use in Consent Form

HIPAA Authorization Form- Outside Sponsored Research

HIPAA Authorization Form- Investigator Sponsored Research

De-Identified Data Form

 

Exempt and NCI CIRB Initial Reviews:

Minimal risk research studies may qualify as exempt from full LBH IRB review.  The Exemption Screening Questions Form will assist you in determining whether your study qualifies as exempt. 

The LBH IRB is a participant in the National Cancer Institute (NCI) Central Institutional Review Board (CIRB) initiative.  Any study that has been reviewed by the NCI CIRB may be submitted to the LBH IRB for a facilitated review.  The LBH IRB requires a letter requesting a Facilitated Review of the NCI CIRB protocol, the protocol and all documentation from the Participants Area downloaded from the CIRB website, and the documents listed below.

 Exempt Submission:                                               NCI CIRB Submission:

Exemption Screening Questions	NCI CIRB Application Checklist
Claim of Exemption Form	NCI CIRB Facilitated Application for New Research
Waiver of Disclosure for PHI	LBH IRB - CIRB Authorization Agreement
De-Identified Data Form	Co-Investigator Signature Form
Informed Consent Exception Request	Financial Interest Disclosure
	Investigator Delegation Form
	Consent Form Template
	HIPAA Text for Use in Consent Form
	HIPAA Authorization Form- Outside Sponsored Research

 

 

 Humanitarian Use Device (HUD) Reviews:

A Humanitarian use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals per year in the United States.  An  investigator, or sponsor may submit a request for HUD designation to the FDA, and must include the following information:  A statement that the applicant is requesting HUD designation for a rare disease or condition, the name and address of the applicant, a description of the rare disease or condition for which the device is to be used, a description of the device, and documentation with authoritative reference appended, to demonstrate that the device is designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 people in the United States per year.  Once approved, this device must be stored separately from all other devices. Please review the Humanitarian Use Devices  Guideline and the Humanitarian Use Devices (HUD) FDA Training Module.

Humanitarian Use Device (HUD) Submission:

Humanitarian Use Device Application and Instructions

Humanitarian Use Devices (HUD) Information & Signature Form

Human Gene Transfer/Recombinant DNA Reseaerch

Humanitarian Device Consent to Undergo Treatment

Humanitarian Device Consent and Privacy Authorization Form

 Renewal Submission Documents: 

Renewal Submission Form	Other Forms
Renewal Application	Adverse Events
	SAE & SRs Annual Report
	Translation Certification Form

 Guidelines

Adverse Events

Adverse Event and Safety Report Continuing Review Reporting

Case Reports and Chart Reviews

De-Identified Data

Humanitarian Use Devices

Humanitarian Use Devices (HUD) FDA Training Module

NCI CIRB

Policy of Conflict of Interest in Research

Conflict of Interest Guidelines for Clinical Research

Defining Community Outreach Research and Non-Research Projects

IRB Review Fees

Evaluating and Monitoriing Risk in Human Subjects Research

Exemption for Human Subjects Research Training

Human Gene Transfer/Recombinant DNA Research

Emergency and Compassionate Use of an Unapproved Drug, Device, or Biologic

Expanded Access For An Unapproved Drug, Biologic, or Device

Questionnaires by Telephone or Mail

Independent Central Instituational Review Board Evaluation and Facilitated Review

Federalwide Assurance of Protection for Human Subjects

Department Residency Research Programs

Retrospective Research

Study Closure

Translation of Foreign Language Document

Evaluating Significant Risk and Non-Significant Risk Device Studies

IRB Fees

Initial Review, Full Board	$2,000
Initial Review, Expedited	$1,000
Continuing Review	$   500
Review for Exempt Status	$   500
Review of Amendments, Revisions, or Modifications:	$   500
Payable to:	LifeBridge Health IRB

HIPAA Policy

LifeBridge Health HIPAA Policy #4 - Use of Protected Health Information for Research(PDF)

Education Requirements

You have the following options for completing the required training requirements:

CITI Course: The Protection of Human Research Subjects -www.citiprogram.org or comparable education from another institution

HIPAA Appendices

Instructions for Individual Authorization Form for Use or Disclosure of Protected Health Information (PHI) for Research Purposes (Word format)

Application for Waiver of Individual Authorization for Use or Disclosure of Protected Health Information (PHI) in a Research Study (Word format)

Request for Use or Disclosure of Protected Health Information (PHI) Preparatory to Research (Word format)

Request for Use or Disclosure of Protected Health Information (PHI) of Decedents (Word format)

Guidance and Regulatory Links

The Belmont Report

IRB Guidebook

45 CFR 46: DHHS-Protection of Human Subjects

FDA 21 CFR 50 Protection of Human Subjects FDA 21 CFR 56 Institutional Review Boards

FDA Information Sheets: Guidance for IRBs and Clinical Investigators

US Department of Health and Human Services

Federal Drug Administration

National Institutes of Health